Designing and Optimization of Modified Dissolution Apparatus for Evaluation of Medicated Chewing Gum of Ambroxol HCl

 

Dr. S. J. Daharwal*, Veena Devi Thakur, Shikha Shrivastava and Bhanu Pratap Sahu

University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (C.G.) India

*Corresponding Author E-mail: daharwalresearch@rediffmail.com

 

ABSTRACT:

Chewing gums cannot be assayed unlike tablet by the conventional method that is by crushing the tablet and weighing an accurate amount of medicament and estimating its content. For estimation of the drug content and the study of drug release process from chewing gums a new apparatus (Erweka’s DRT 6 Chewing apparatus) has been designed which mimics the natural chewing actions. The drug content was found to be in the range of 95.20 to 99.21% or 28.56 to 29.76 mg. highest drug content and  the lowest drug content were found with  formulation F5 and formulation F7 of Ambroxol hydrochloride respectively. The present study deals with in-vitro drug release of Medicated chewing gumFormulation F5showed highest drug release of 98.74% and formulation F7 showed  lowest drug release of 85.74% respectively at the end of 30 minutes.

 

KEYWORDS: Erweka DRT 6 chewing apparatus, medicated chewing gum,  Ambroxol HCl.

 

 

1. INTRODUCTION

Number of apparatus for studying in-vitro drug release for medicated chewing gum has been developed1. An apparatus for in-vitro drug release testing of medicated chewing gum has been developed by Kvist C2. They have studied the effect chewing surfaces, twisting movement of surfaces and temperature of test medium on release rate of drug from MCG3. Another novel dissolution apparatus has been developed for MCG by Rider JN. the apparatus consist of conical Teflon base and a rotating, ribbed teflon plunger suspended in a dissolution vessel. The rotation speed, plunger frequency, medium volume, medium type, medium sampling location, number of plunger ribs and number of gum pieces were studied by them4.In this report we discuss dissolution apparatus and evaluation of In-vitro release of medicated chewing gum of AmbroxolHcl by using modified and optimized.

 

1.1Novel apparatus design for MCG

1.1.1Erweka’s DRT 6 Chewing apparatus

One of the noncompendial apparatus commercially available was designed by Wennergren. The schematic representation of the Wennergren chewing apparatus5 is shown in figure 1.1. The chewing procedure consist of reciprocation of the lower surface in combination with a shearing (twisting ) movement of the upper surface that provides mastication of the chewing gum and at the same time adequate agitation of the test medium. The upper jaw has a flat surface that is parallel to the central part of the lower surface. The small brim of the lowersurface is angled upwards (45 degree) so that the lower surface function as a small bowl with a flat bottom. The bowl prevents the chewing from sliding during mastication. Investigations of the performance of the chewing apparatus with multiple drug products were published by Wennergren et al. the influences of different operational parameters of the chewing gum apparatus on drug release have been carefully investigated.

 

Figure 1: ERWEKA DRT 6 Chewing Apparatus

 

1.2 Advantages of modified in vitro drug release apparatus (Figure-2)

To use circular nets of inert polymer to keep the chewing gum in place between the jaw during analysis.

 

2. MATERIAL AND METHODS:

2.1 Estimation of drug contents and drug release study: the study of drug release process a new apparatus (Erweka’s DRT 6 Chewing apparatus) has been designed.

 

2.2 Stability study:

The short term stability study of optimized formulation was performed as per ICH guidelines at 25ºC±5ºC and 65% ± 5% RH for three months and evaluated color and hardness.

 

Figure-2: Modified In-Vitro Drug Release Apparatus for MCG

 

3. METHODOLOGY:

3.1. Procedure for estimation of drug contents6:

The test cell was filled with 900 ml of Phosphate buffer 6.8. The chewing gum was placed and operated the instrument for 60 min at a chewing frequency of 60 strokes per minute, to ensure total release of the drug from the formulation in the 6.8 phosphate buffer. From the dissolution medium 10 ml was withdrawn and the absorbance of the resulting solution was read at 245 nm. The amount of drug present in the formulation was calculated using regression coefficient.

 

3.2. Procedure to estimate the drug release from the formulation (in-vitro release)7:Procedure was followed as mention in section 3.1 sample was used at different time intervals of 5, 10, 15, 20, 25 and 30 minutes. After each withdrawal of the sample, 10 ml of fresh 6.8 phosphate buffer was replaced to maintain the sink condition as there is no need of dilution.

 

Table 1: Cumulative % drug release of developed formulations

Time

(min)

% Cumulative drug release    

F1

F2

F3

F4

F5

F6

G7

F8

F9

05

28.20

26.43

26.74

27.10

29.76

27.33

24.86

25.86

26.20

10

46.00

44.76

45.30

44.86

48.42

45.09

42.76

44.66

45.43

15

60.66

60.42

60.83

59.76

63.52

60.29

57.09

58.39

60.19

20

73.09

73.52

74.73

74.09

76.98

74.29

68.85

70.85

73.32

25

84.75

84.75

87.63

83.75

88.64

86.85

78.41

81.28

83.98

30

93.51

95.31

97.50

92.35

98.74

96.75

85.74

88.18

91.74

 

Figure 2: In-vitro release profile of Ambroxol HCl from developed formulations

 

 

4. RESULT AND DISSCUSSION:

The prepared formulation of Ambroxol hydrochloride chewing gum were analysed for the drug content  was found to be in the range of 95.20 to 99.21% or 28.56 to 29.76 mg.highest drug content was 29.76 mg and  the lowest drug content was  28.56 mg of medicated chewing gum formulation F5 and formulation F7 of Ambroxol hydrochloride respectively.

 

The in-vitro drug release study by Erweka’s DRT 6 chewing apparatus was used for Formulation F5 andformulation F7 showed highest drug release of 98.74% and  lowest drug release of 85.74% respectively at the end of 30 minutes. . The in-vitro drug release of different  formulations followed the order: F5>F3>F6>F2>F1> F4>F9>F8>F7.Finally, it is concluded that Chewing gum is an excellent delivery system for drugs intended for the local and systemic therapy. It is possible to design medicated chewing gum of Ambroxol hydrochloride, mainly for the treatment of bronchitis and related conditions where efficacy and patient compliance are of prime importance.

 

5. REFERENCES:

1.        European Pharmacopoeia, Strasbourg: European Directorate For the Quality of Medicines. Chewing Gum: Medicated, 5th Edition, 2004.

2.        Kvist C, Andersson S B, Fors S, Wennergren B, Berglund J, Apparatus for studying in vitro drug release from medicated chewing gums, International Journal of Pharmaceutics, 1999:189(1): 57-65.

3.        Kvist C L, Andersson S B, Berglund J, Wennergreen B, Fors S M, ” Equipment for drug release testing of medicated chewing gum”, Journal of Pharmaceutical and Biomedical Analysis, 22 (2000) 405-411.

4.        James N Rider, Ed L Brunson, Walter G Chambliss, Robert W Cleary, Ahmed H Hikal, Peggy H Rider et al, Development and Evaluation of a novel apparatus for medicated chewing gum products. Pharm. Res.1992, 9, 255-259.

5.        European Directorate for the Quality of Medicines, Council of Europe, European Pharmacopeia. Suppl. 5.2. General Monograph 2.9.25: Dissolution Test for Medicated Chewing Gum, 5th Ed, Strasbourg, France, 2005, 3116-3117.

6.        Pandey S, Goyani M and Devmurari V, “Development, In-vitro evaluation and physical characterization of medicated chewing gum: Chlorehexidinegluconate” Scholars Reseach Library Der Pharmacia Lettre, 2009, 1(2):  286-292.

7.        Agrawal A, Sudhakar C K and Jain S, “Development. In-vitro evaluation and physical characterization of medicated chewing gum: GranisetronHCl”, Novel Science International Journal of Pharmaceutical Sciences, 2012, 1(5): 216-219.

 

 

Received on 18.06.2013          Accepted on 25.07.2013        

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Asian J. Pharm. Res. 3(3): July-Sept. 2013; Page 141-143